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Changes to IRB Regulations: New Exemption Categories and Continuing Review Updates

Starting 1/21/2019, there will be new exemption categories and regulatory clarifications in IRB regulations. Most studies will no longer require continuing review. Changes have been made to the content on Informed Consent forms. Single IRB of Record process for multi-site studies, non-exempt, and NIH funded projects. New self-determination Wufoo forms available. Follow the steps on the new website to determine if your project requires oversight.

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Changes to IRB Regulations: New Exemption Categories and Continuing Review Updates

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  1. Common Rule

  2. IRB Regulation Changes - starting 1/21/2019 • New exemption categories and regulatory clarifications • Continuing review no longer required for most studies • Changes in content on Informed Consent forms • Single IRB of Record – multi-site study, non-exempt, NIH funded - a single IRB reviews and approves

  3. New IRB processes – starting 1/21/2019 • New exemption categories added, and clarification of older categories – this will result in many projects now meeting exempt criteria • New self-determination Wufoo forms available, all investigators should start with these forms, as the long hard copy form may now not need to be submitted

  4. STEP 1: See new website - does your project need oversight at all or does it fit one of new categories?

  5. OUTCOMES from STEP 1: Does my project require oversight? • If answer is “no”, a determination email that project doesn’t meet regulatory requirements for oversight by IRB; or • If answer is “yes”, a determination email that project needs oversight and then you follow STEP 2 & 3 instructions Copy of these emails also sent to IRB too.

  6. Step 2: Do you have survey, interview questions, or list of topics ready to upload?ANDDo you have information sheet, consent form or justification for waiver of documentation of informed consent ready to upload?

  7. STEP 3: Does research fit ONLY ONE of exempt categories – if yes, use Wufoo form if no, submit hard copy form • 45 CFR 46.104(d)(1) – research in educational settings involving normal educational practices (instructional strategies; effectiveness of techniques, curricula, classroom management methods) • 45 CFR 46.104(d)(2)- educational tests, surveys, interviews, public behavior – now includes identifiable results & audiovisual recordings • 45 CFR 46.104(d)(3) – benign behavioral interventions with collection of information from adults – includes identifiable results & audiovisual recordings. Ex. Online game play, solving puzzles under various noise conditions, deciding how to split cash between participants

  8. OUTCOMES from STEP 3: Does my project meet exempt criteria? • Submission confirmation email sent to PI upon Wufoo form completion and form sent to IRB. • IRB reviews submission and sends determination email that project meets regulatory requirements for oversight, but meets one of the exempt review categories; or  C) IRB sends determination email that project needs to have a full IRB protocol form filled out and submitted for review.

  9. Continuing Review Changes Expedited protocols – Submitted after 1/21/2019 • Approved with no expiration date • No Continuing Review paperwork to keep protocol active No Changes - Full Review protocols – still have expiration date and must submit continuing review paperwork before expiration date • Annual status checks will continue, starting 90 days from last date checked • Completion Reports required for expedited and full protocols

  10. Informed Consent – template use required • Key elements section required for consent forms longer than 6 pages • Additional statements required if identifiable private information, biospecimens, clinically relevant results or whole genome sequencing • Informed Consent templates will be posted on the IRB website and must be used starting 1/21/2019.

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